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Completed

NCT Number: NCT06231901

Comparison of CO-OP and GDT on Occupational Performance and Functional Status in the CP

This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care.

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Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cognitive Orientation Goals Nervous System Diseases Occupational Problems Orientation, Spatial Spatial Behavior

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

About this study

Cerebral palsy (CP) is a group of neurological disorders that affect movement, muscle tone, and posture, causing activity limitations that originated in the developing fetal or infant brain that are attributed to non-progressive disorders. Symptoms such as spasticity and contracture in CP cause a decrease in functional skill level with limitations in daily living activities such as learning a new skill or self-dressing and handwriting. In this disease, the simultaneous presence of sensory, cognitive, perceptual, and behavioral impairments significantly undermines the acquisition and execution of functional skills, autonomy in daily living, and active engagement in leisure activities. This study was planned to investigate and compare the impact of CO-OP and GDT on the occupational performance and functional status of children with CP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being between 5-10 years of age
  • being diagnosed with CP
  • having adequate language abilities to make contact with a therapist and be informed during intervention.

Exclusion criteria

  • they were receiving any other treatment
  • they had been diagnosed with mental retardation
  • they had serious vision or hearing problems.

Treatment and study plan

CO-OP

Other

With a task-specific and goal-focused CO-OP approach; it is aimed to increase one's skills, to teach to use self-generated cognitive strategies, and to encourage generalization and transfer to new situations and activities.

Other names: Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach

GDT

Other

Goal-directed training included the active implementation of task-specific activities related to the child's functional goals. Focusing on motor learning, GDT is an activity-based approach to therapy that uses meaningful, self-selected goals to provide opportunities for problem solving and indirectly guide the movements necessary to successfully meet task demands

Other names: goal directed training

Traditional occupational therapy

Other

The program included functional one-handed and two-handed training and consisted of advice and treatment aimed at reducing spasticity, improving hand function and activities of daily living, and providing appropriate orthoses. It also includes techniques aimed at improving impairment (e.g., stretching, sensory stimulation) and strengthening activities (e.g., motor training, environmental modification, performing specific target activities) to help participants achieve their individual goals.

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: "up to 12 weeks"

    COPM is used to help individuals describe occupational performance problems and precedence in the areas of self-care, productivity, and leisure, in which they have difficulty performing.

  2. Pediatric Evaluation of Disability Inventory (PEDI):

    Time frame: "up to 12 weeks"

    PEDI is a measurement tool used to evaluate the functional status of children.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Comparison of Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach and Goal-Directed Training on Occupational Performance and Functional Status in Children With Cerebral Palsy: A Three-Armed Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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